Effect of Novel Nasoalveolar Molding Techniques on Parents' Satisfaction and Short Term Treatment Outcomes in Unilateral Cleft Lip and Palate Infants: A Randomized Controlled Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2019-04-30

Brief Summary

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The aim of this trial is to figure out the efficiency of modified Grayson NAM on parents' satisfaction, nasal esthetics, interlabial gap and maxillary arch changes. NAM might improve and facilitate the surgical procedure after lip closure. This might decrease the need of further interventions to improve esthetics and function of CLP patients. This trial will help the patients and practitioners in taking the decision of inclusion of NAM in the CLP treatment protocol as a mandatory step or skip a useless procedure with all of its burden.

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Detailed Description

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In this randomized trial, 4 groups will be included. The first group will receive a modified nasoalveolar molding appliance in addition to taping. In the second group, the patient will receive the CAD/NAM. the third group is tape only, while the fourth group remain untreated. the follow-up period will be 3 months till surgical lip closure. the assessment will be through a questionnaire for the parents' satisfaction outcome, photographs for nasal esthetics and interlabial gap outcome and maxillary models for the maxillary dimension change outcome.

Conditions

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Cleft Lip and Palate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Modified Nasoalveolar molding group

This group will receive nasoalveolar molding appliance in addition to taping for 3 Months with follow-up every 2 weeks.

Group Type EXPERIMENTAL

Modified Nasoalveolar molding

Intervention Type DEVICE

Infants will receive this appliance which is a maxillary plate with nasal stent in addition to taping on the upper lip (taping is routine step in Grayson's nasoalveolar molding technique).

Taping group

Tape will be used alone in this group on the upper lip segments for 3 months with follow-up every 2 weeks.

Group Type EXPERIMENTAL

Taping

Intervention Type DEVICE

Infants will receive a tape only on the upper lip segments to mold it to touch each other.

Control group

This group will not receive any treatment.

Group Type NO_INTERVENTION

No interventions assigned to this group

CAD/NAM group

Computer Aided Designed Nasoalveolar molding and 3D printed.

Group Type EXPERIMENTAL

CAD/NAM

Intervention Type DEVICE

computer aided design NAM

Interventions

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Modified Nasoalveolar molding

Infants will receive this appliance which is a maxillary plate with nasal stent in addition to taping on the upper lip (taping is routine step in Grayson's nasoalveolar molding technique).

Intervention Type DEVICE

Taping

Infants will receive a tape only on the upper lip segments to mold it to touch each other.

Intervention Type DEVICE

CAD/NAM

computer aided design NAM

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Infants with age range from 7 - 30 days.
2. Unilateral complete cleft lip and alveolus.
3. Presence of unilateral cleft palate.
4. Medically free subjects.
5. Both males and females.

Exclusion Criteria

1. Patients older than 30 days.
2. Syndromic patients with other defects in addition to cleft lip and palate.
3. Patients with bilateral cleft lip and palate.
4. Incomplete Cleft lip.
5. Medically compromised patients.

Minimum Eligible Age

7 Days

Maximum Eligible Age

30 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes